Arbutus Biopharma Corporation has reacquired China rights to its lead compound, imdusiran, from Qilu Pharmaceutical, terminating their strategic partnership for the development, manufacturing, and commercialization of imdusiran in Greater China. This move comes as Qilu reprioritizes its pipeline efforts, allowing Arbutus to once again hold global rights for imdusiran, which has achieved functional cure in eight patients in two phase 2a trials.
To support its focus on advancing its pipeline efficiently, Arbutus has formed a new Scientific Advisory Board (SAB) including globally recognized leaders in the treatment of chronic hepatitis B virus (CHBV). The SAB members, with extensive experience in late-stage clinical trials, will advise Arbutus on its strategic evaluation of its CHBV pipeline.
In terms of clinical data, across all phase 2a trials conducted with imdusiran, Arbutus has reported a total of 8 patients who have been functionally cured and were able to discontinue all therapies, including nucleos(t)ide analogue (NA) therapy. Two of the patients who achieved functional cure received no interferon (IFN) as part of their treatment, and seven of the eight patients had baseline hepatitis B surface antigen (HBsAg) levels less than 1000 Iu/ml.
Imdusiran (AB-729) is an RNAi therapeutic designed to reduce all HBV viral proteins and antigens, including hepatitis B surface antigen, which is considered essential for reawakening a patient’s immune system to control the virus. The clinical data generated thus far has shown imdusiran to be generally safe and well-tolerated, while also providing meaningful reductions in HBsAg and hepatitis B virus DNA.
Chronic HBV infection represents a significant unmet medical need, with approximately 250 million people worldwide suffering from it. Arbutus is currently developing imdusiran (AB-729) and an oral PD-1 inhibitor (AB-101) for the treatment of chronic HBV infection, with ongoing efforts to protect and defend its intellectual property, subject to ongoing lawsuits against Moderna and Pfizer/BioNTech for the use of Arbutus’s patented LNP technology in their COVID-19 vaccines. As a result of these announcements, the company's shares have moved 0.45% on the market, and are now trading at a price of $3.385. For more information, read the company's full 8-K submission here.
